Hiring company: Gilead
CLINICAL OPERATIONS: Clinical Operations is responsible for the execution of all Phase 1-4 clinical trials, across all therapeutic areas, around the world. In partnership with Clinical Research, Medical Affairs and Development Operations functions, ensures that all clinical trial activities are performed in accordance with all applicable SOPs, company policies and regulatory guidelines to provide timely delivery of high quality clinical data to support global registration and commercialization of Gilead’s products.
Sr. Clinical Trials Management Associate, Clinical Operations (Sr. CTMA)
We are seeking a talented, experienced, and highly motivated candidate to join the Clinical Operations team supporting our Oncology programs.
Specific Responsibilities and Skills for Position:
- Prioritize multiple tasks, plan proactively, and accomplish goals using well-defined instructions
- Participate in and manage project meetings and conference calls with CROs, vendors, and multi-functional teams
- Able to anticipate obstacles and proactively develop solutions to achieve project goals
- Develop a general understanding of functional issues and routine project goals from an organizational perspective Participate in abstract presentations, oral presentations, and manuscript development activities
- Interact and cooperate with individuals in other functional areas to address routine study issues
- Develop tools and processes that increase measured efficiencies of the project
- Assist in trainings for Clinical Trials Management Associates (CTMAs) and Clinical Project Assistants (CPAs),
- Assist in selecting Contract Research Organizations (CROs) or vendors
- Coordinates CROs and vendors
- Responsible in updating of study timelines
- Participate in departmental, or interdepartmental, strategic initiatives under general supervision
- Assist in review of routine data and preparation of safety, interim, and final study reports, and resolution of data discrepancies
- Conduct site evaluation, initiation, co-monitoring, and closeout visits, in addition to the routine monitoring visits
- Assure the site compliance with the protocol and regulatory requirements for GS studies
- Draft and coordinate review of protocols, informed consents, case report forms, and study plans as needed
- Travel may be required
Knowledge:
- Excellent verbal, written, interpersonal and presentation skills are required
- Knowledge of FDA and/or EMA Regulations (or relevant local regulations), ICH Guidelines, and GCP governing the conduct of clinical studies
- Working knowledge and experience with Word, PowerPoint, Project and Excel
Experience and Skills:
- 4+ years of experience and a RN (2 or 3 year certificate) or BS/BA in a relevant scientific discipline
- 2+ years of experience and a Masters' degree or higher; scientific discipline preferred
- Oncology experience highly preferred